Vaccination remains our most powerful tool in battling this pandemic. We encourage all members of our community to get vaccinated. Due to the recent rise in COVID-19 cases, we are continuing to bolster our efforts to keep our community safe and healthy by evaluating our policies and plans. We have updated our FAQs to answer pressing questions.
What procedures should be followed for on-site monitoring of clinical trials? (1-1-22)
From the CCTS: External monitors are essential to the ongoing oversight of clinical research activities. For industry sponsored clinical trials, a contract is executed which includes allowance of sponsor representatives to come onsite to monitor the data collected throughout the life of a research study for data integrity and participant safety purposes.
With approval from UKHealthcare leadership we will allow on‐site monitoring within CCTS facilities as long as the following requirements are adhered to:
Scheduling: In person monitor visits utilizing the CCTS must:
Schedule the visit with the appropriate CCTS staff member(s) at least 1 week prior to the visit. The CCTS staff will confirm that a location is available within the CCTS. If space is not available, the study team will be responsible for locating a space in which social distancing can be maintained for the visit and notifying the CCTS staff. Visits occurring within less than a week’s notice will NOT be accommodated and if not scheduled ahead of time we cannot guarantee a location will be available for the monitor.
Proof of vaccination will be required at the time of scheduling. A copy of the CDC card indicating the second dose in a 2‐dose series (Pfizer‐BioNTech or Moderna), or receipt of one dose of a single‐dose (Johnson & Johnson) FDA authorized vaccine ≥2 weeks prior to the scheduled visit date. The study monitor can email proof of vaccination to the CCTS staff member.
In the event that a monitor is not vaccinated they must submit a request for an exemption due to a medical contraindication or sincere religious belief to the CCTS. Documentation that verifies a medical exemption must include:
- Recognized clinical contraindications to COVID‐19 vaccines;
- Date and signature by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws;
- All information specifying which of the authorized COVID‐19 vaccines are clinically contraindicated for the HCW to receive and the recognized clinical reasons for the contraindications; and
- A statement by the authenticating practitioner recommending that the HCW be exempted from the facility’s COVID‐19 vaccination requirements based on the recognized clinical contraindications.
This request will be reviewed and approval must be granted prior to coming on‐site. Unvaccinated monitors must also submit a negative PCR COVID test result that has been performed within 72 hours of the visit to the CCTS staff member prior to arriving on site.
Monitors must go through the UKHC entrance screening point and answer the following questions:
- Do you have a new cough unrelated to seasonal allergies?
- Do you have muscle aches/pain?
- Do you have new shortness of breath?
- Do you have a new sore throat (not associated with seasonal allergies)?
- Do you have vomiting or diarrhea?
- Do you have a fever of 100.0 or greater?
- Have you experienced a loss of taste or smell?
If two or more questions are answered yes the monitor will not be allowed into the facility.
- Once screened monitors will be given an entry pass. They will need to present this to the CCTS team member upon arrival to the CCTS.
- The monitor must wear a mask at all times. The monitor or study team will be responsible for providing all PPE. Plastic screen shields are available as needed.
- Social Distancing is expected and hand washing encouraged.
During the visit:
- A time will be scheduled for the monitor to meet with CCTS staff member(s). The monitor should have all questions prepared to limit the amount of time of the face-to‐face interaction. Anything that is able to be addressed remotely should be done remotely.
- The study monitor will be provided with all documents for the monitoring visit.
- The study team should provide the monitor with contact information in the event that they require assistance.
- The CCTS staff will meet with the monitor at their scheduled time to address any questions the monitor may have. The monitor will need to be prepared at the scheduled time. Many CCTS staff are working remotely and their office space has been reassigned. Therefore, CCTS staff time on campus is limited.
- At the conclusion of the visit the monitor should wipe down the binders and leave them in the area/room. The CCTS staff will retrieve them.
Termination of on‐site privileges:
In the event that a study monitor does not abide by the above requirements on‐site monitoring privileges maybe revoked.
Reference: UKHC Policy A03‐125
What requirements do research vendors and site monitors need to follow? (9-8-21)
Research vendors and site monitors are not permitted in UK HealthCare spaces in Tier 4 operations. Site monitoring needs to be conducted remotely for all studies other than COVID-19 vaccine trial research. If a monitor is provided an exemption for COVID-19 related research, the monitor must follow the vaccine requirements of UK HealthCare.
More information on remote monitoring can be found at the following web site:
Can I host high school students in my research laboratory? (9-8-21)
Research that is NOT being conducted in a UK HealthCare (UKHC) clinical setting is currently operating under institutional guidelines as addressed in the Fall 2021 Guidebook for UK students. The guidebook requires that prior to being allowed access to in-person facilities and programs, UK students must provide the institution with their vaccine verification or be subject to weekly testing. For high school students who want to work with UK researchers we have established the following process to verify that these students adhere to institutional guidelines:
- Principal Investigator (PI) interacts with high school student and agrees to oversee their research within the PI’s program.
- PI communicates to the high school student that they will need to have their school certify that the student complies with UK requirements and provide to the student the following instructions to obtain verification.
- Student’s school, using official letterhead, directly submits certification for the student (or group of students) to the OVPR:
- Certification should include the name of the PI and name of the high school student.
- This certification does NOT require the actual vaccination record, but instead a statement indicating certification that: “This individual is in compliance with University of Kentucky requirements to have students vaccinated or tested weekly for COVID-19 in order to be on UK’s campus and/or conduct research with UK faculty, students or staff.”
- If the high school chooses not to certify (for example, because they do not have testing capabilities), then a parent should provide this certification letter.
- Certification letter should be sent from the high school to OVPR at email@example.com.
- OVPR receives the certification request and then provides approval to the PI to proceed.
- PI and students should follow all other required paperwork from Environmental Health and Safety in order to have a minor in a laboratory and student must follow university policies related to mask wearing, etc. as outlined in the playbook.
Please note: High school students are not permitted to do research in a UKHC facility (clinics or other UKHC spaces) as defined here: https://ukhealthcare.uky.edu/hospitals-clinics
How are we handling research involving human participants? (9-8-21)
In-person human participants research that is NOT in a UK HealthCare clinical setting will follow the university guidelines for masking when in indoor spaces. These researchers are NOT mandated to have the vaccine, but if they are not vaccinated then they need to be tested weekly according to university guidelines. See community research question below for additional helpful information pertaining to human participants research.
Human participants research that occurs in UK HealthCare facilities (clinics or other spaces) will follow the specific UK HealthCare requirements.
Researchers performing community research with human participants should use precautions (distancing, mask wearing, time limitations within certain spaces) and if the researcher is not vaccinated, they should follow university guidelines for weekly testing.
How can I perform community research involving human participants as safely as possible? (9-8-21)
Our guiding principle is maintaining the safety of the research participants and the research team members. Given the current concerns about the COVID-19 delta-variant outbreak and the real or perceived risk of exposure, the risk/benefit ratio of research participation must be taken into careful consideration for each IRB-approved protocol at UK. Ethical principles of research and the federal regulations for protecting human research participants all require an acceptable risk/benefit ratio. Community-engaged research protocols offer special challenges to the health and safety of research personnel and participants as this type of research may take place with extensive networks of people, increasing the potential for rapid and mass exposure. Research staff and participants may not be aware that they are COVID-19 positive and could be carriers of the virus.
In-person community-engaged research protocols should employ standard safety recommendations (social distancing, hand washing, mask wearing, and overall risk mitigation to the extent possible). In an effort to prevent exposure of potential participants, research teams and the general public to the COVID-19 virus, please follow any restrictions or requirements issued for/by the locations/facilities in which the human participant research takes place. If the research involves special circumstances or populations (e.g., minors in a school or other settings such as a community center), it is important to abide by the rules of the location but also make sure that parents and others who give consent are fully informed about risks and any measures taken to minimize those risks.
Community-engaged investigators and their teams are encouraged to provide educational resources related to safe COVID practices to their participants. Please contact the UK Office of Research Integrity via firstname.lastname@example.org or 859-257-9428 with questions.
When did the Resumption of Research Phased Plan end? (6-11-21)
On June 10, 2021, President Capilouto announced campus measures (those policy changes are detailed in FAQs below) to emerge from the pandemic to be implemented beginning Monday, June 14, 2021.
At this time, the University of Kentucky Resumption of Research Phased Plan will end, and researchers should operate based on University guidance. See Lisa Cassis' email with details for researchers.
How do the policy changes impact health college employees and people in medical annex spaces? (6-11-21)
For health colleges or employees in physical proximity to UK HealthCare facilities, this means that if you are in a purely academic space (office, classroom, or other area) that is not managed by UK HealthCare follow the minimum campus requirements highlighted in the President's message. If you are in facilities managed primarily by the UK HealthCare enterprise (including clinics and hospitals) you will be expected to meet the more stringent requirements set by HealthCare. If a faculty or staff member has questions about the classification of the space they work in, they can email email@example.com. HealthCare will be sending a follow-up email to people in facilities that they manage. Also, if you complete a daily screener from UK HealthCare, that means you work in spaces primarily managed by the health care enterprise and you should continue to follow those guidelines.
What policy changes have been made for employee vaccination, masking and testing? (9-21-21)
- Vaccines are not mandated for campus employees, but strongly encouraged.
- Those who have been vaccinated must verify that status with the university. Upload vaccination documentation here, via our self-report tool.
- UK will accept all vaccines approved by the World Health Organization.
- Please see the campus COVID-19 Vaccine Information site for more.
- All individuals, regardless of vaccination status, must wear masks or face coverings in indoor spaces on campus where people gather — including, but not limited to, classrooms, the Gatton Student Center, shared office spaces, hallways and common spaces. For more see the Fall 2021 Guide masking section.
- Testing requirements for non-vaccinated students and employees can be found here: Student, Employee and Community COVID-19 Testing.
What policy changes have been made for employee offices, classrooms, events, travel, dining and transportation? (6-11-21)
Beginning June 14, on campus, the following changes will be implemented:
Offices and Classrooms
- Given UK’s successful vaccination efforts — and our ongoing efforts to communicate about vaccines — offices and classrooms will return to normal configurations this summer and fall, in accordance with CDC guidelines.
- Over the summer, UK officials — including the START team and in accordance with federal and state guidelines — will monitor this issue as we prepare for the fall. As always, our top priority will be the health and safety of our campus community.
Events, Activities and Athletics
- We are planning to return our Athletics events to full capacity in fall 2021.
- Capacity for on-campus events will return to 2019 policies, which allow for greater capacity and attendance.
- The university will follow CDC guidelines, which continue to be updated, with respect to international travel.
- UK will remove the language and guidance currently in place, which discourages domestic travel. We will add language strongly encouraging members of our community to be fully vaccinated before traveling.
- Dining halls and other related facilities will operate at normal capacity.
- COVID-19 safety protocols and support — such as plexiglass, hand sanitizing stations and healthy behaviors signage — will remain in place.
- While not eating, individuals who are not vaccinated are asked to either wear a mask or maintain an appropriate physical distance from others.
- UK will lift all capacity restrictions on university vehicles.
What do I do if one of my staff tests positive for COVID-19? (6-11-21)
Department management should ask the employee to notify UK Health Corps firstname.lastname@example.org.
Vaccinated campus employees are no longer required to participate in daily COVID-19 screening. HealthCare employees will continue to follow the daily screening process currently in place.
If you have general questions about the daily screener, please email email@example.com or call 859-218-SAFE.
More information can be found at https://www.uky.edu/coronavirus/do-your-part/screening.
What is the latest guidance on research-related international travel? (6-16-21)
The following new guidelines around international travel among members of our community have been updated and are aligned with CDC guidance:
- Effective immediately, fully vaccinated employees may conduct UK-endorsed international travel to any country that the CDC has designated a risk level 3 or lower for COVID-19 without completing an additional review process.
- All UK-endorsed travel to these countries must be registered in the university’s international travel registry.
- Fully vaccinated employees who wish to travel to a country designated as a risk level 4 by the CDC must complete an additional review/approval process through the university’s Director of International Health, Safety and Security, Jason Hope (firstname.lastname@example.org).
- Employees who are not fully vaccinated must also complete an additional review/approval process through the university’s Director of International Health, Safety and Security before traveling to any international destination, regardless of risk level.
- All international airline tickets for UK-endorsed travel must be purchased through UK Travel Services.
- International travel requests by students, including graduate students, and Education Abroad programs, will continue to be reviewed and approved on a case-by-case basis in alignment with UK Administrative Regulation 4:9.
All international travelers should be aware that many countries continue to implement border restrictions, quarantine periods and testing requirements. It is essential for travelers to understand the landscape in their destination country so that they are prepared for any logistical challenges they may encounter.
Learn more: https://www.uky.edu/ufs/travel-services
What leave options are available to myself and/or employees if we test positive for COVID-19?
If you are not well enough to work – whether at your normal work location or remotely – you should request sick leave, or Temporary Disability Leave (TDL). If you are unable to work due to the care of a sick family member, you should request sick leave.
How can I decontaminate my workspace?
Housekeeping/custodial groups will be cleaning high-touch surfaces in common areas such as doorknobs, light switches, elevator buttons and handrails. Cleaning of high-touch surfaces in labs, offices, and other similar areas that will not be cleaned by housekeeping can be cleaned by individuals following CDC guidelines and the EPA's approved disinfectants list.